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Completed

NCT Number: NCT07755046

Repetitive Transcranial Magnetic Stimulation for Alcohol Use Disorder

This study looked at whether repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation treatment, could help adults with alcohol use disorder when added to their usual treatment. Nine adults receiving abstinence-oriented care received 10 sessions of stimulation over the right front part of the brain. Drinking severity, mood, craving and quality of life were assessed before treatment, immediately after the 10 sessions, and again at one and three months. Brain scans were also obtained at these visits to examine whether stimulation was associated with changes in brain connections. The study had no comparison group, so the results cannot show whether any change was caused by the stimulation.

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Key information

Conditions

Alcohol Use Disorder (AUD) Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital, Taiwan

Taichung, Taiwan, 407219

About this study

This was a single-arm, open-label pilot study conducted at a single medical centre in Taiwan. Adults aged 20 to 65 years with DSM-5 alcohol use disorder were enrolled during inpatient or outpatient abstinence-oriented care, after the treating physician confirmed that acute withdrawal had stabilized.

Stimulation was delivered over the right dorsolateral prefrontal cortex at the F4 position using a Magstim Rapid2 system with a figure-of-eight D70 mm air film coil: 10 sessions at 10 Hz and 110% of the visually determined resting motor threshold, 60 trains of five seconds each, 3,000 pulses per session over approximately 30 minutes, delivered on consecutive weekdays. Concomitant pharmacological and psychosocial treatment continued as usual care and was not protocolized.

Assessments were conducted at baseline, after the tenth session, and at one and three months, and comprised clinical measures (Alcohol Use Disorders Identification Test, Patient Health Questionnaire-9, craving visual analogue scales, WHOQOL-BREF) and multimodal magnetic resonance imaging (resting-state functional MRI, diffusion tensor imaging and magnetic resonance spectroscopy).

The study was originally approved as a one-year, randomized, double-blind, sham-controlled trial with a larger planned sample. Funding constraints and difficulty recruiting this population prevented completion of that design, and the study was conducted as a single-arm, open-label pilot with follow-up to three months. The trial was registered retrospectively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 20 to 65 years
  • Diagnosis of alcohol use disorder according to DSM-5 criteria
  • Able to provide written informed consent and complete study procedures

Exclusion criteria

  • Moderate to severe alcohol withdrawal
  • Psychiatric symptoms interfering with alcohol use disorder treatment
  • Acute physical illness requiring hospitalization
  • Standard contraindications to repetitive transcranial magnetic stimulation
  • Pregnancy or planned pregnancy within one year
  • Formal disability certification related to a psychiatric disorder

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

High-frequency repetitive transcranial magnetic stimulation

Primary outcomes

  1. Change in Alcohol Use Disorders Identification Test (AUDIT) total score

    Time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months

    AUDIT total score, range 0 to 40, with higher scores indicating more severe alcohol-related problems. Change from baseline was assessed at each follow-up.

Secondary outcomes

  1. Change in Patient Health Questionnaire-9 (PHQ-9) score

    Time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months

    PHQ-9 total score, range 0 to 27, higher scores indicating more severe depressive symptoms.

  2. Change in craving visual analogue scale score

    Time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months

    Visual analogue scale, range 0 to 10, higher scores indicating stronger craving.

  3. Change in WHOQOL-BREF total score

    Time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months

    WHOQOL-BREF (Taiwan version) total score, higher scores indicating better quality of life.

  4. Change in resting-state functional connectivity

    Time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months

    Whole-brain and network-level functional connectivity derived from resting-state functional MRI using the Schaefer 100-parcel, seven-network atlas.

  5. Change in white matter diffusion metrics

    Time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months

    Fractional anisotropy and mean diffusivity derived from diffusion tensor imaging.

  6. Change in brain metabolite concentrations

    Time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months

    Metabolite concentrations measured by single-voxel magnetic resonance spectroscopy.

  7. Adverse events

    Time frame: Throughout the stimulation course and follow-up, up to 3 months

    Adverse events elicited by open-ended enquiry at each stimulation session and imaging visit.

Sponsors and collaborators

Lead sponsor

Ting-Gang Chang

Other

Registry information

Official study title

Therapeutic Effects of Repetitive Transcranial Magnetic Stimulation on Alcohol Use Disorder: A One-Year, Randomized, Double-Blind MRI Tracking Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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